(34 days)
TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drugs or drug metabolites in urine at or above the stated cutoff concentrations.
Cutoff Concentrations:
Amphetamines: 1000 ng/mL
Benzodiazepines: 200 ng/mL
Cocaine metabolite: 300 ng/mL
Methamphetamine: 500 ng/mL
Morphine: 300 ng/mL
Morphine (M2K): 2000 ng/mL
Phencyclidine (PCP): 25 ng/mL
Tetrahydrocannabinols (THC): 50 ng/mL
TesTcup II and CupKit products provide only a preliminary analytical test result. A more reliable analytical method must be used in order to obtain a confirmed analytical result.
The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission are in vitro diagnostic tests intended for professional use for the qualitative detection of amphetamines (d,l-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL) and morphine 2000 (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL), and THC (11-nor-Δ 9 -THC-9-carboxylic acid 50 ng/mL).
The assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber.
Urine is collected directly in the test cup provided. The drug profile card is placed in the samples by inserting it into the lid holder, then securing the lid onto the cup. Urine is drawn in the profile card by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band.
When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A preliminary positive ("non-negative" result is the absence of a blue band).
An additional antibody/antigen reaction occurs at the "VALID" area. The "VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, interact with and bind to the antigen on the blue microparticles.
This document describes the validation of the OnTrak TesTcup® II and OnSite CupKit™ for the qualitative detection of various drugs and drug metabolites in urine.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Precision" study are implicitly stated as:
- Greater than 95% confidence level that negative results will be attained with drugs at 25% (1/4 X) of their respective cutoff concentrations.
- Greater than 95% confidence level that positive results will be attained with drugs at 150% (1/2 X, presumably meant to be 1.5X) of their respective cutoff concentrations.
The "Accuracy" section compares the device results to GC/MS, and the "Comparison with predicate device" section compares it to existing devices. Rather than explicit acceptance criteria, these sections present overall percent agreement, indicating that a high level of agreement (e.g., typically >95%) is desired for clinical performance.
| Drug/Metabolite | Cutoff Concentration | Performance at 25% Cutoff (Negative Results % - Lot 1 / Lot 2) | Performance at 150% Cutoff (Positive Results % - Lot 1 / Lot 2) | Overall Accuracy vs. GC/MS (No explicit criterion, but reported values) | Overall Agreement vs. Predicate Device (No explicit criterion, but reported values) |
|---|---|---|---|---|---|
| Precision | |||||
| Amphetamine | 1000 ng/mL | 100% / 100% (at 250 ng/mL) | 100% / 100% (at 1500 ng/mL) | N/A | N/A |
| Morphine | 2000 ng/mL | 100% / 100% (at 500 ng/mL) | 100% / 100% (at 3000 ng/mL) | N/A | N/A |
| PCP | 25 ng/mL | 100% / 100% (at 6.25, 12.5 ng/mL) | 100% / 100% (at 37.5 ng/mL) | N/A | N/A |
| Benzodiazepines | 200 ng/mL | 100% / 100% (at 50 ng/mL) | 100% / 100% (at 300 ng/mL) | N/A | N/A |
| Cocaine metabolite | 300 ng/mL | 100% / 100% (at 75 ng/mL) | 100% / 100% (at 450 ng/mL) | N/A | N/A |
| THC | 50 ng/mL | 100% / 100% (at 12.5, 25 ng/mL) | 100% / 100% (at 75 ng/mL) | N/A | N/A |
| Morphine | 300 ng/mL | 100% / 100% (at 75, 150 ng/mL) | 100% / 100% (at 450 ng/mL) | N/A | N/A |
| Methamphetamine | 500 ng/mL | 100% / 100% (at 125 ng/mL) | 100% / 100% (at 750 ng/mL) | N/A | N/A |
| Accuracy (Overall Performance vs. GC/MS) | |||||
| THC | 50 ng/ml | N/A | N/A | - 0% false positives for negative samples, 0% false negatives for >125% cutoff samples. Some 'near cutoff' samples were negative. | 98% |
| Cocaine | 300 ng/ml | N/A | N/A | - 0% false positives for negative samples, 0% false negatives for >125% cutoff samples. Some 'near cutoff' samples were negative. | 100% |
| PCP | 25 ng/ml | N/A | N/A | - 0% false positives for negative samples, 0% false negatives for >125% cutoff samples. Some 'near cutoff' samples were negative. | 99% |
| Amphetamine | 1000 ng/ml | N/A | N/A | - 0% false positives for negative samples. 2 false negatives reported for >125% cutoff samples (values 1569, 1776 ng/mL). | 97% |
| Methamphetamine | 500 ng/ml | N/A | N/A | - 0% false positives for negative samples, 0% false negatives for >125% cutoff samples. Some 'near cutoff' samples were negative. | 100% |
| Morphine | 300 ng/ml | N/A | N/A | - 0% false positives for negative samples, 0% false negatives for >125% cutoff samples. | 100% |
| Morphine (M2K) | 2000 ng/ml | N/A | N/A | - 0% false positives for negative samples, 0% false negatives for >125% cutoff samples. Some 'near cutoff' samples were negative. | 96% |
| Benzodiazepines | 200 ng/ml | N/A | N/A | - 0% false positives for negative samples, 0% false negatives for >125% cutoff samples. | 100% |
2. Sample size used for the test set and the data provenance
Precision Study:
- Sample Size: 63 replicates were tested for each scenario (drug, concentration, lot). Since there were 6 concentration levels, 2 lots, and 8 drugs/metabolites, this means a total of (63 replicates * 6 concentrations * 2 lots * 8 drugs) = 6048 individual tests for precision.
- Data Provenance: The specimens were "contrived specimens containing drugs or drug metabolites at various concentrations." The drugs/metabolites were spiked into "negative human urine pool." This indicates a prospective study using artificially prepared samples. Country of origin is not specified, but typically studies for US FDA PMA/510k are conducted within the US or under comparable standards.
Accuracy Study (Clinical Specimens):
- Sample Size (for comparison with GC/MS):
- THC: 100 Negative, 13 (75-100% cutoff), 6 (100-125% cutoff), 31 (>125% cutoff) = 150 samples.
- Cocaine: 100 Negative, 6 (75-100% cutoff), 7 (100-125% cutoff), 35 (>125% cutoff) = 148 samples.
- PCP: 100 Negative, 8 (75-100% cutoff), unknown (100-125% cutoff, implied range for 0 positive), 37 (>125% cutoff) = 145+ samples (the 100-125% is zero positive, not clear if cases were tested in that range)
- Amphetamine: 100 Negative, 8 (75-100% cutoff), 0 (100-125% cutoff), 29+2 (false negative) (>125% cutoff) = 139 samples.
- Methamphetamine: 100 Negative, 2 (75-100% cutoff), 0 (100-125% cutoff), 48 (>125% cutoff) = 150 samples.
- Morphine (300 ng/ml): 100 Negative, 0 (75-100% cutoff), 0 (100-125% cutoff), 46 (>125% cutoff) = 146 samples.
- Morphine (2000 ng/ml): 100 Negative, 3 (75-100% cutoff), 0 (100-125% cutoff), 35 (>125% cutoff) = 138 samples.
- Benzodiazepines: 100 Negative, 0 (75-100% cutoff), 0 (100-125% cutoff), 50 (>125% cutoff) = 150 samples.
- Data Provenance: "Clinical specimens." The study was evaluated in a "SAMHSA certified laboratory." "Clinical negative samples were screened negative by an automated immunoassay and reported as negative according to SAMHSA guidelines. Clinical specimens screened positive by an automated immunoassay." Some samples were diluted. This indicates retrospective clinical samples, likely obtained from a bank or collected as part of routine testing, then characterized further for the study.
Comparison with Predicate Device:
- Sample Size:
- THC: 147 samples (47+3+0+100)
- Cocaine: 150 samples (48+0+0+102)
- PCP: 150 samples (41+1+0+108)
- Amphetamines: 150 samples (36+4+0+110)
- Methamphetamine: 158 samples (56+0+0+102)
- Morphine (300 ng/ml): 161 samples (61+0+0+100)
- Morphine (M2K): 150 samples (41+6+0+103)
- Benzodiazepines: 164 samples (64+0+0+100)
- Data Provenance: "All of the above clinical specimens" were used, referring to the same clinical specimens as for the GC/MS comparison. This implies retrospective clinical samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Precision Study: The ground truth was established by spiking known concentrations of drugs/metabolites into negative human urine. This is a controlled experimental setup, not relying on expert interpretation for ground truth.
Accuracy Study (Clinical Specimens): The ground truth was established using GC/MS (Gas Chromatography/Mass Spectrometry), which is the gold standard for confirmatory drug testing. No human experts are explicitly mentioned as establishing the ground truth for these quantitative results. The interpretation of the device's qualitative results is then compared to the GC/MS quantitative results against the defined cutoffs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
There is no indication of an adjudication method in the traditional sense (e.g., for image interpretation needing multiple readers). The device produces a qualitative positive/negative result, which is then compared against quantitative GC/MS results or predicate device results. For the precision study, 3 operators tested replicates, but this was to assess reproducibility, not to adjudicate an uncertain "ground truth."
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This document describes an in vitro diagnostic device, a rapid urine drug screen. It is not an AI-assisted diagnostic tool that involves human readers or interpreters in the way an MRMC study would typically evaluate (e.g., radiology interpretation). Therefore, no MRMC comparative effectiveness study was done, and the concept of "human readers improve with AI vs without AI assistance" is not applicable here. The device itself is the 'diagnostic tool' being evaluated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this entire study is a standalone performance evaluation of the OnTrak TesTcup® II and OnSite CupKit™. The device provides a direct qualitative result (presence or absence of a blue band), and its performance is assessed against established quantitative methods (GC/MS) or predicate devices. There is no human intervention or interpretation of the immediate test result that would constitute a "human-in-the-loop performance" in the sense of an algorithm assist. The "operators" in the precision study are performing the test procedure, not interpreting ambiguous results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Precision Study: Known concentrations of spiked drugs/metabolites in negative human urine.
- Accuracy Study (Clinical Specimens): GC/MS (Gas Chromatography/Mass Spectrometry), which is the analytical gold standard for confirmatory drug detection and quantification.
8. The sample size for the training set
This document describes a diagnostic device (immunoassay), not a machine learning algorithm that requires a training set in the conventional sense. Therefore, there is no "training set" described. The development of such devices involves chemical and biological optimization, not data-driven model training.
9. How the ground truth for the training set was established
As there is no training set for a machine learning model, this question is not applicable.
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| 510(k) Summary | |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| 1) Submitter name, address, contact | Varian, Inc.25200 Commercentre DriveLake Forest, CA 92630(949) 770-9381Contact: Lorna Gamboa |
|---|---|
| Date Prepared: | December 15, 2003 |
| 2) Device Name | Proprietary Name: OnTrak TesTcup® II and OnSite CupKit™Panel: Toxicology |
|---|---|
| ---------------- | ---------------------------------------------------------------------------------- |
| Classification Name: | Product Code | Regulation Number |
|---|---|---|
| Enzyme Immunoassay, Amphetamine | DKZ | 862.3100 |
| Enzyme Immunoassay, Benzodiazepine | JXM | 862.3170 |
| Enzyme Immunoassay, Cocaine and Cocaine Metabolite | DIO | 862.3250 |
| Enzyme Immunoassay, Opiate | DJG | 862.3650 |
| Enzyme Immunoassay, Phencyclidine | LCM | Unclassified |
| Enzyme Immunoassay, Cannabinoids | LDJ | 862.3870 |
| Thin Layer Chromatography, Methamphetamine | DJC | 862.3610 |
| 3) Predicate Device | We claim substantial equivalence to these currently marketed devices:OnTrak TesTcup® 501, K001421, 7/12/2000OnTrak TesTcup 5 M2K, K994017, 1/27/2000OnTrak TesTstik BNZ, K983174, 11/18/98OnTrak TesTstik® 2 COC/THC, K994164, 4/13/2000 |
|---|---|
| --------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 4) Device Description | The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission are in vitro diagnostic tests intended for professional use for the qualitative detection of amphetamines (d,l-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL) and morphine 2000 (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL), and THC (11-nor-Δ 9 -THC-9-carboxylic acid 50 ng/mL). |
|---|---|
| ----------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
The assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membranc in the test chamber.
{1}------------------------------------------------
| Urine is collected directly in the test cup provided. The drug profile card is placedin the samples by inserting it into the lid holder, then securing the lid onto the cup.Urine is drawn in the profile card by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In theabsence of drug, the antibody is free to interact with the drug conjugate, causingthe formation of a blue band. | |
|---|---|
| When drug is present in the specimen, it binds to the antibody-coatedmicroparticles. If sufficient drug is present, the microparticles are inhibited frombinding the drug conjugate and no blue band is formed at the result window. Apreliminary positive ("non-negative" result is the absence of a blue band). | |
| An additional antibody/antigen reaction occurs at the "VALID" area.The"VALID" blue band forms when antibodies, which are imbedded in the reagentmembrane, interact with and bind to the antigen on the blue microparticles. | |
| 5) Statement ofIntended Use | OnTrak TesTcup II and OnSite Cupkit assays are intended for professional use forthe qualitative detection of amphetamines (d,l-amphetamine 1000 ng/mL),benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), morphine(morphine 300 ng/mL) and morphine 2000 (morphine 2000 ng/mL), PCP(phencyclidine 25 ng/mL), and THC (11-nor-A9-THC-9-carboxylic acid 50ng/mL). |
| 6) TechnologicalCharacteristics | See "Summary of Testing" on the following pages. |
| SubstantialEquivalence | The TesTcup II and CupKit devices have the same intended use and incorporatethe same fundamental scientific technology as the predicate devices. |
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510(k) Summary (continued)
Summary of testing
Precision
The precision of TesTcup II and CupKit was determined by three operators across three different days, who tested 63 replicates on two lots using contrived specimens containing drugs or drug metabolites at various concentrations. The drug or drug metabolites were spiked into negative human urine pool and assayed by GC/MS. The results are summarized in the tables below.
All lots are required minimally to perform with a greater than 95% confidence level that negative results will be attained with drugs at 25% (1/4 X) of their respective cutoff concentrations, and a greater than 95% confidence level that positive results will be attained with drugs at 150% (1/-1/2 X) of their respective cutoff concentrations.
| Amphetamine (ng/ml) | Precision Results (%) | |||
|---|---|---|---|---|
| Cutoff = 1000 ng/ml | Lot 1 | Lot 2 | ||
| + | - | + | - | |
| 0 | 0 | 100 | 0 | 100 |
| 250 | 0 | 100 | 0 | 100 |
| 500 | 12.7 | 87.3 | 4.8 | 95.2 |
| 750 | 93.6 | 6.4 | 88.9 | 11.1 |
| 1250 | 100 | 0 | 100 | 0 |
| 1500 | 100 | 0 | 100 | 0 |
| Morphine (ng/ml)Cutoff = 2000 ng/ml | Precision Results (%) | |||
|---|---|---|---|---|
| Lot 1 | Lot 2 | |||
| + | - | + | - | |
| 0 | 0 | 100 | 0 | 100 |
| 500 | 0 | 100 | 0 | 100 |
| 1000 | 6.3 | 93.7 | 0 | 100 |
| 1500 | 80.9 | 19.1 | 31.7 | 68.3 |
| 2500 | 100 | 0 | 100 | 0 |
| 3000 | 100 | 0 | 100 | 0 |
| PCP (ng/ml)Cutoff = 25 ng/ml | Lot 1 | Lot 2 | ||
|---|---|---|---|---|
| + | - | + | - | |
| 0 | 0 | 100 | 0 | 100 |
| 6.25 | 0 | 100 | 0 | 100 |
| 12.5 | 0 | 100 | 0 | 100 |
| 18.75 | 4.7 | 95.3 | 6.3 | 93.7 |
| 31.25 | 95.2 | 4.8 | 100 | 0 |
| 37.5 | 100 | 0 | 100 | 0 |
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| Benzodiazepines (ng/ml)Cutoff = 200 ng/ml | Precision Results (%) | |||
|---|---|---|---|---|
| Lot 1 | Lot 2 | |||
| + | - | + | - | |
| 0 | 0 | 100 | 0 | 100 |
| 50 | 0 | 100 | 0 | 100 |
| 100 | 6.3 | 93.7 | 22.2 | 77.8 |
| 150 | 49.2 | 50.8 | 46 | 54 |
| 250 | 100 | 0 | 100 | 0 |
| 300 | 100 | 0 | 100 | 0 |
| Cocaine (ng/ml)Cutoff = 300 ng/ml | Precision Results (%)Lot 1 | Lot 2 | ||
|---|---|---|---|---|
| + | - | + | - | |
| 0 | 0 | 100 | 0 | 100 |
| 75 | 0 | 100 | 0 | 100 |
| 150 | 55.6 | 44.4 | 19 | 81 |
| 225 | 100 | 0 | 93.7 | 6.3 |
| 375 | 100 | 0 | 100 | 0 |
| 450 | 100 | 0 | 100 | 0 |
| THC (ng/ml) | Precision Results (%) | |||
|---|---|---|---|---|
| Cutoff = 50 ng/ml | Lot 1 | Lot 2 | ||
| + | - | + | - | |
| 0 | 0 | 100 | 0 | 100 |
| 12.5 | 0 | 100 | 0 | 100 |
| 25 | 0 | 100 | 0 | 100 |
| 37.5 | 0 | 100 | 9.5 | 90.5 |
| 62.5 | 96.8 | 3.2 | 100 | 0 |
| 75 | 100 | 0 | 100 | 0 |
| Morphine (ng/ml)Cutoff = 300 ng/ml | Precision Results (%) | |||
|---|---|---|---|---|
| Lot 1 | Lot 2 | |||
| + | - | + | - | |
| 0 | 0 | 100 | 0 | 100 |
| 75 | 0 | 100 | 0 | 100 |
| 150 | 0 | 100 | 0 | 100 |
| 225 | 17.5 | 82.5 | 1.6 | 98.4 |
| 375 | 100 | 0 | 100 | 0 |
| 450 | 100 | 0 | 100 | 0 |
:
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| Methamphetamine(ng/ml)Cutoff = 500 ng/ml | Precision Results (%)Lot 1 | Lot 2 | ||
|---|---|---|---|---|
| + | - | + | - | |
| 0 | 0 | 100 | 0 | 100 |
| 125 | 0 | 100 | 0 | 100 |
| 250 | 6.3 | 93.7 | 0 | 100 |
| 375 | 79.4 | 20.6 | 66.7 | 33.3 |
| 625 | 100 | 0 | 100 | 0 |
| 750 | 100 | 0 | 100 | 0 |
Specificity
The following structurally similar compounds for amphetamine, benzodiazepines, cocaine, methamphetamine, morphine, PCP and THC were tested for cross reactivity with TesTcup II/CupKit. memailling, its primered in normal human urine. The results are expressed as that amount of the compound capable of giving a result equivalent to the cutoff for that assay.
| Amphetamine-related Compounds | Minimum Concentration Required to give a positive result (ng/ml) |
|---|---|
| d-Amphetamine | 500 |
| Methylenedioxyamphetamine (MDA) | 5000 |
| l-Amphetamine | 25,000 |
| β-Phenethylamine | 100,000 |
| d,l-Phenylpropanolamine | 100,000 |
| d,l-Methamphetamine | >100,000 |
| Benzodiazepines-related Compounds | Minimum Concentration Required to give apositive result (ng/ml) |
|---|---|
| 7-Aminoflunitrazepam | 100 |
| Bromazepam | 100 |
| Didesethylflurazepam | 100 |
| 7-Aminonitrazepam | 100 |
| α-Hydroxyalprazolam | 100 |
| α-Hydroxytriazolam | 100 |
| Norfludiazepam | 100 |
| Nordiazepam | 100 |
| Temazepam | 100 |
| Clonazepam | 250 |
| Lorazepam | 250 |
| Chlorazepate | 250 |
| Flurazepam | 250 |
| Desmethylflunitrazepam | 250 |
| Alprazolam | 250 |
| Diazepam | 250 |
| Demoxepam | 500 |
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| Triazolam | 500 |
|---|---|
| Hydroxyethylflurazepam | 1000 |
| Flunitrazepam | 1000 |
| Chlordiazepoxide | 2000 |
| Cocaine-related Compounds | Minimum Concentration Required to give apositive result (ng/ml) |
|---|---|
| Cocaine HCl | >100,000 |
| Methamphetamine-related Compounds | Minimum Concentration Required to give apositive result (ng/ml) |
|---|---|
| Propylhexedrine | 1000 |
| d,l-Methamphetamine | 2000 |
| 3,4-Methylenedioxymethamphetamine (MDMA) | 2000 |
| l-Methamphetamine | 3000 |
| Fenfluramine | 5000 |
| p-Hydroxymethamphetamine | 5000 |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 10,000 |
| d-Amphetamine | 25,000 |
| l-Phenylephrine | 50,000 |
| d,l-Ephedrine | 50,000 |
| Ranitidine | 50,000 |
| β-Phenethylamine | 50,000 |
| d,l-Amphetamine | 50,000 |
| 3,4-Methylenedioxyamphetamine (MDA) | 100,000 |
| l-Amphetamine | >100,000 |
| Morphine-300-related Compounds | Minimum Concentration Required to give apositive result (ng/ml) |
|---|---|
| Codeine | 250 |
| Ethyl morphine HCl | 250 |
| Dihydrocodeine bitartrate | 500 |
| 6-Acetylmorphine | 500 |
| Hydrocodone bitartrate | 500 |
| Morphine-3-glucuronide | 500 |
| Hydromorphone HCl | 1000 |
| Nalorphine | 2000 |
| Thebaine | 3000 |
| Levorphanol | 25,000 |
| Rifampin | 50,000 |
| N-Norcodeine HCl | 100,000 |
| Oxycodone | 100,000 |
| Meperidine | 100,000 |
| Atropine | >100,000 |
| THC-related Compounds | Minimum Concentration Required to give apositive result (ng/ml) |
11-hydroxy - Δ° THC
50,000
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| Morphine-2000-related Compounds | Minimum Concentration Required to give a positive result (ng/ml) |
|---|---|
| Codeine | 2000 |
| 6-Acetylmorphine | 2000 |
| Ethyl morphine HCl | 3000 |
| Dihydrocodeine bitartrate | 3000 |
| Morphine-3-glucuronide | 3000 |
| Hydrocodone bitartrate | 10,000 |
| Hydromorphone HCl | 10,000 |
| Nalorphine | 25,000 |
| Thebaine | 50,000 |
| Levorphanol | >100,000 |
| Rifampin | >100,000 |
| Oxycodone | >100,000 |
Cross-Reactivity with Additional Drugs
The following compounds were tested at 100,000 ng/ml and found not to cross-react with the (OnTrak TesTcup II or Onsite CupKit) assays (except as noted).
Acetominophen Acetylsalicylic acid 6-Acetylmorphine (except morphine assay) Alprazolam (except benzodiazepine assay) 7-Aminoflunitrazepam (except benzodiazepine assay) 7-Aminonitrazepam (except benzodiazepine assay) d.l-Amphetamine (except amphetamine and methamphetamine assay) d-Amphetamine (except amphetamine and methamphetamine assay) I-Amphetamine (except amphetamine and methamphetamine assay) Atropine Benzocaine Benzphetamine Bromazepam (except benzodiazepine assay) (±) Brompheniramine Buprenorphine Bupropion Chlorazepate (except benzodiazepine assay) Chlordiazepoxide (except benzodiazepine assay) Clonazepam (except benzodiazepine assav) Cocaine HCI (except Cocaine assay) Codeine (except morphine assay) Demoxepam (except benzodiazepine assay) Desmethylflunitrazepam (except benzodiazepine assay) Dextromethorphan Dextrorphan Diazepam (except benzodiazepine assay) Didesethylflurazepam (except benzodiazepine assay) Dihydrocodeine bitartrate (except morphine assay) Diphenhydramine d, l-Methamphetamine (except methamphetamine assay)
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Doxylamine d.l-Ephedrine (except methamphetamine assay) Ethyl morphine HCI (except morphine assay) Fenfluramine (except methamphetamine assay) Fenoprofen Flunitrazepam (except benzodiazepine assay) Flurazepam (except benzodiazepine assay) Gemfibrozil Hydrochlorothiazide Hydrocodone bitartrate (except morphine assay) Hydromorphone HCl (except morphine assay) a-Hydroxyalprazolam (except benzodiazepine assay) Hydroxybupropion Hydroxyethylflurazcpam (except benzodiazepine assay) >-Hydroxymethamphetamine (except methamphetamine assay) a-Hvdroxytriazolam (except benzodiazepine assay) Ibuprofen Ketamine Lansoprazole Levorphanol (except morphine assay) Lidocaine Lorazepam (except benzodiazepine assay) MDA (except amphetamine and methamphetamine assay) MDEA (except methamphetamine assay) MDMA (except methamphetamine assay) Meperidine (except morphine assay) d-Methamphetamine (except methamphetamine assay) d, l-Methamphetamine (except amphetamine and methamphetamine assay) I-Methamphetamine (except methamphetamine assay) Methylphenidate Morphine-3-glucuronide (except morphine assay) Nalorphine (except morphine assay) Naproxen N-Norcodeine HCl (except morphine assay) Nordiazepam (except benzodiazepine assay) Norfludiazepam (except benzodiazepine assay) Oxycodone (except morphine assay) B-Phenethylamine (except amphetamine and methamphetamine assay) /-Phenvlephrine (except methamphetamine assay) d.l-Phenvlpropanolamine (except amphetamine assay) Propylhexedrine (except methamphetamine assay) Quinidine Quinine Ranitidine (except methamphetamine assay) Rifampin (except morphine assay) Temazepam (cxcept benzodiazepine assay) Thebaine (except morphine assay) 11-hydroxy - A THC (except THC assay) A THC Triazolam (except benzodiazepine assay)
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Accuracy
TesTcup II and CupKit was evaluated in a SAMHSA certified laboratory using clinical specimens. The clinical negative samples were screened negative by an automated immunoassay and reported as negative according to SAMHSA guidelines. Clinical specimens screened positive by an automated immunoassay accessible to brinners goal binnel. Some samples were diluted with negative human urine to achieve the appropriate test range. Results are summarized below.
| THCCutoff = 50ng/ml | NegativeSamples | Near Cutoff | > 125% of cutoff | ||
|---|---|---|---|---|---|
| 75% to 100% ofCutoff | 100% to 125% ofcutoff | ||||
| + | 0 | 13 | 6 | 31 | |
| - | 100 | 0 | 0 | 0 |
Comparison with Reference Method (GC/MS):
| CocaineCutoff = 300ng/ml | NegativeSamples | GC/MS Values (ng/ml) | ||
|---|---|---|---|---|
| Near Cutoff | > 125% of cutoff | |||
| + | 0 | 75% to 100% ofCutoff | 100% to 125% ofcutoff | > 125% of cutoff |
| 6 | 7 | 35 | ||
| - | 100 | 1 | 1 | 0 |
| PCPCutoff = 25ng/ml | NegativeSamples | GC/MS Values (ng/ml) | > 125% of cutoff | ||
|---|---|---|---|---|---|
| Near Cutoff | |||||
| + | 0 | 75% to 100% ofCutoff | 100% to 125% ofcutoff | 37 | |
| - | 100 | 8 | 0 | 0 |
| AmphetamineCutoff = 1000ng/ml | NegativeSamples | GC/MS Values (ng/ml) | |||
|---|---|---|---|---|---|
| Near Cutoff | |||||
| 75% to 100% ofCutoff | 100% to 125% ofcutoff | > 125% of cutoff | |||
| + | 0 | 6 | 5 | 29 | |
| - | 100 | 8 | 0 | 2* |
*GC/MS values for these samples were 1569 ng/mL and 1776 ng/mL.
| MethamphetamineCutoff = 500ng/ml | NegativeSamples | GC/MS Values (ng/ml)Near Cutoff | > 125% of cutoff | ||
|---|---|---|---|---|---|
| 75% to 100% ofCutoff | 100% to 125% ofcutoff | ||||
| + | 0 | 3 | 5 | 48 | |
| - | 100 | 2 | 0 | 0 |
{9}------------------------------------------------
| MorphineCutoff = 300ng/ml | NegativeSamples | GC/MS Values (ng/ml) | ||
|---|---|---|---|---|
| Near Cutoff | > 125% of cutoff | |||
| 75% to 100% ofCutoff | 100% to 125% ofcutoff | |||
| + | 0 | 7 | 8 | 46 |
| - | 100 | 0 | 0 | 0 |
| Morphine(M2K)Cutoff = 2000ng/ml | NegativeSamples | GC/MS Values (ng/ml)Near Cutoff | > 125% of cutoff | ||
|---|---|---|---|---|---|
| 75% to 100% ofCutoff | 100% to 125% ofcutoff | ||||
| + | 0 | 7 | 5 | 35 | |
| - | 100 | 3 | 0 | 0 |
| BenzodiazepinesCutoff = 200ng/ml | NegativeSamples | GC/MS Values (ng/ml)Near Cutoff | > 125% of cutoff | |
|---|---|---|---|---|
| 75% to 100% ofCutoff | 100% to 125% ofcutoff | |||
| + | 0 | 6 | 8 | 50 |
| - | 100 | 0 | 0 | 0 |
Comparison with predicate device
All of the above clinical specimens were also tested by, and results compared to, OnTrak TesTcup and OnTrak TesTstik. Results are summarized below.
| THC | TesTstik 2 | ||
|---|---|---|---|
| Overall percent agreement = 98% | + | - | |
| New Test | + | 47 | 3 |
| - | 0 | 100 |
| Cocaine | ||
|---|---|---|
| Overall percent agreement = 100% | ||
| New Test | TesTstik 2 + | TesTstik 2 - |
| + | 48 | 0 |
| - | 0 | 102 |
| PCPOverall percent agreement = 99% | TesTstik 2 | ||
|---|---|---|---|
| + | - | ||
| New Test(CupKit) | + | 41 | 1 |
| - | 0 | 108 |
{10}------------------------------------------------
| Amphetamines | TesTstik 2 | ||
|---|---|---|---|
| Overall percent agreement = 97% | + | - | |
| New Test | + | 36 | 4 |
| - | 0 | 110 |
| MethamphetamineOverall percent agreement = 100% | TesTstik 2 | ||
|---|---|---|---|
| + | - | ||
| New Test | + | 56 | 0 |
| - | 0 | 102 |
| MorphineOverall percent agreement = 100% | TesTstik 2 | ||
|---|---|---|---|
| New Test | + | + | - |
| - | 61 | 0 | |
| 0 | 100 |
| Morphine 2000 (M2K)Overall percent agreement = 96% | TesTstik 2 | ||
|---|---|---|---|
| New Test | + | + | - |
| - | 0 | 103 | |
| + | 41 | 6 |
| BenzodiazepinesOverall percent agreement = 100% | TesTstik 2 | ||
|---|---|---|---|
| + | - | ||
| New Test | + | 64 | 0 |
| - | 0 | 100 |
:
:
{11}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 0 2004
Ms. Lorna Gamboa Regulatory Affairs Manager Varian, Inc. 25200 Commercentre Drive Lake Forest, CA 92630
K033902 Re:
Trade/Device Name: On Trak TesTcup® II and OnSite CupKit™ Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: January 13, 2004 Received: January 14, 2004
Dear Ms. Gamboa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass suace in to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, ateres, provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny 1 out all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{12}------------------------------------------------
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{13}------------------------------------------------
Indications for Use Statement
K033902 510(k) Number:________________________________________________________________________________________________________________________________________________________________
Device Name: __ OnTrak TesTcup® II and OnSite CupKit™_________________________________________________________________________________________________________________________
Indications for Use:
TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for t es reap if and Capitiv of drugs or drug metabolites in urine at or above the stated cutoff concentrations.
Cutoff Concentrations:
| Amphetamines: | 1000 ng/mL | Morphine: | 300 ng/mL |
|---|---|---|---|
| Benzodiazepines: | 200 ng/mL | Morphine (M2K): | 2000 ng/mL |
| Cocaine metabolite: | 300 ng/mL | Phencyclidine (PCP): | 25 ng/mL |
| Methamphetamine: | 500 ng/mL | Tetrahydrocannabinols (THC): | 50 ng/mL |
TesTcup II and CupKit products provide only a preliminary analytical test result. A more res reap it and Caprevical method must be used in order to obtain a confirmed analytical result.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
ileuk Cule
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
KO33102 510(k) _______________________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).